Chengdu, China — 2025.08.20 Zennova Pharmaceuticals today announced that its Chengdu manufacturing facility has received an Establishment Inspection Report (EIR) from the FDA, after successfully completing a current Good Manufacturing Practice (cGMP) inspection conducted by the U.S. Food and Drug Administration (FDA) during Mar. 17th-22nd, 2025 confirming that the facility operates in full compliance with regulatory standards.

The FDA’s issuance of an EIR represents an important regulatory recognition that the facility is operating in compliance with cGMP standards. This achievement underscores Zennova’s unwavering commitment to maintaining the highest levels of quality, safety, and compliance in its manufacturing operations.

“We are proud of this accomplishment, which reflects the dedication of our Chengdu team and our strong quality management systems,” said Dahai Guo, CEO of Zennova. “The successful completion of the FDA inspection reinforces Zennova’s ability to support global partners with reliable, compliant, and high-quality pharmaceutical products.”

In addition to advancing its own pipeline, Zennova also provides contract research development and manufacturing organization (CRDMO) services, leveraging its cGMP-compliant facilities to support partners worldwide with formulation development, scale-up, and commercial manufacturing.

The Chengdu manufacturing facility occupies 8 acres of encircled campus and  over 300,000 sfq of state-of-the-art cGMP construction.  It serves as a strategic hub for Zennova’s development and production activities. The successful FDA inspection further strengthens the company’s capability to advance its pipeline and expand its global presence, while providing assurance to partners and patients alike that Zennova operates at internationally recognized standards.

Zennova remains committed to continuous improvement, regulatory compliance, and innovation in pharmaceutical manufacturing. The company will continue to build on this milestone to deliver safe, effective, and high-quality medicines to meet global health needs.

About Zennova

Zennova is a pharmaceutical company dedicated to advancing healthcare through innovative research, high-quality manufacturing, and global regulatory excellence. Alongside its proprietary drug development programs, Zennova offers comprehensive CDMO services, providing global partners with expertise in formulation development, manufacturing, and regulatory support. With a strong commitment to compliance and patient safety, Zennova partners with healthcare providers worldwide to deliver trusted medicines.